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Subclinical Hypothyroidism | The TRUST Study - Depression Substudy

Subclinical Hypothyroidism research study

What is the primary objective of this study?

Mild thyroid failure is a common condition among older adults and has been associated with
numerous adverse effects on health, such as cardiovascular disease, cognition disturbances
and muscular problems. Mild thyroid failure has also been associated with an increased risk
of developing depression. To date, only few studies have investigated the effect of thyroid
hormone replacement on depression in patients with mild thyroid failure. This study therefore
aims to assess whether thyroid hormone replacement in older adults with mild thyroid failure
is associated with a decrease in the presence of depressive symptoms. This study forms a
substudy of a large international study on thyroid hormone replacement in older adults with
mild thyroid failure (the TRUST study).

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LevothyroxineThe intervention will start with Levothyroxine 50 µg daily (reduced to 25 µg in subjects <50Kg body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) versus matching placebo; at 3 months if the serum TSH level is <0.4 mU/L dose will be reduced by 25 µg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6mUL, additional 25 µg. The process will be repeated at 12 months then annually. Mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine that will be prescribed is 150μg (after 4 increments of 25μg at 3 months, 1, 2 and 3 years; from the starting dose of 50μg).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Experimental: Drug: Levothyroxine The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).

Discuss Levothyroid

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